MalfunctionIOY
FLA ORTHOPEDICS INC'S WORK ABOUT CARPOL MATE.
Received Dec 21, 2005 · Event occurred Dec 10, 2005
Report MW1037252 · MDR key 655818
Device
Generic name
Wrist Support Universal-beige
Manufacturer
Fla Orthopedics Inc.Model number
22-140UNBEGCatalog number
L7-G22140
Lot number
R14871A
Product problems
- Unknown (for use when the device problem is not known)
Patient
50 YR
- Edema
- Erythema
Narrative
Description of Event or Problem
CLIENT DEVELOPED BRIGHT REDNESS AND SEVERE EDEMA OF THE WRIST SHE WORE IT ON. SHE HAD A PERFECT OUTLINE ON HER SKIN OF HER WRIST OF WHERE SHE HAD WRIST SUPPORT TOUCHING HER SKIN. SPOUSE TELLS CO SHE IS NOT ALLERGIC TO LATEX ON METALS WHICH ARE ITEMS OF THE DEVICE ALONG WITH MATERIALS NOT PUBLISHED IN MANUFACTURER'S BROCHURE. CLIENT DID HAVE TO GO TO DR'S OFFICE FOR EVAL AND FURTHER MEDICAL TREATMENT AS ANTIBIOTIC THERAPY.